Senior Clinical Evaluation Specialist (Remote)

Stryker•Portage, MI

3d•Remote

About The Position

The Senior Clinical Evaluation Specialist applies scientific, regulatory and project management skills to establish the evaluation strategy and compile a body of clinical evidence, in order to reach a legally binding scientific conclusion on the safety and performance of medical devices throughout the product lifecycle. This role is Remote supporting our Instruments Division, with preference to candidates in the Eastern United States.

Requirements

A minimum of a bachelor’s degree in a technical and/or scientific discipline required.
Minimum of 2 years industry experience in clinical, quality or regulatory affairs (Risk Management, Design quality, Post Market Safety etc.).
Strong communication, project management and influencing skills.
Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
Ability to travel domestically and internationally, up to 20%.

Nice To Haves

Master’s or Ph.D. or other higher degree in health-related field (RN, BSN, BPharm/MD/MPH).
Experience in scientific or medical writing, relevant academic or clinical research experience (PhD, Post-doc).
Good working understanding of regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.
Good working knowledge of areas linked to clinical evaluation (e.g. regulatory requirements, data analysis, critical appraisal etc.).
Successful track record in managing complex deliverables independently and managing simple projects.
Ability to follow internal procedures and processes and contribute with suggestions for improvements.

Responsibilities

Support a coherent clinical evidence strategy throughout the new product development cycle, and foster alignment with adjacent complex processes (marketing strategy and claims, regulatory strategy, clinical research strategy, testing strategy).
Support compliant and sustainable literature search strategies, and perform complex literature queries to retrieve published clinical data,
Identify, appraise, and analyze all relevant data (clinical, PMS, marketing, testing, etc.) from multiple sources and formats and create a comprehensive scientific review.
Analyze the current medical and scientific trends in the clinical state of the art on a broad variety of specialized indications and techniques.
Identify unanswered questions and residual risks in the clinical evaluation report, and assist with design of Post Market Clinical Follow Up (PMCF) activities in collaboration with clinical affairs colleagues and/or other subject matter experts to address these questions.
Define and develop clinical evaluation and analysis methodologies to adapt to a complex and quickly evolving regulatory and scientific framework.